NCT03929822终止不适用
Contrast-Enhanced Spectral Mammography: Potential to Improve Diagnostic Accuracy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of CESM compared to mammography
研究概览
简要总结
The purpose of this study is to test whether contrast-enhanced spectral mammography (CESM) may be able to reduce the number of unnecessary biopsies in women whose screening mammograms had abnormal findings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women called back from a screening mammography by either FFDM or tomosynthesis with soft tissue abnormalities including masses, asymmetries, focal asymmetries or architectural distortion with or without calcifications. Patients will be questioned regarding the possibility of pregnancy and will need a negative pregnancy test prior the study intervention.
排除标准
- •Age <30 years old
- •Screening mammography with only calcifications abnormalities
- •Male patients
- •Pregnant or lactating patients
- •Patients with any allergy to iodinated contrast
- •Patients with eGFR < 45
- •Patients that may be treated with radioactive iodine
结局指标
主要结局
Diagnostic accuracy of CESM compared to mammography
时间窗: 2 years
The radiologist will interpret the low energy images and record their findings.
次要结局
未报告次要终点
研究者
研究点 (1)
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